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Healing Touch and Relaxation Therapies in Cervical Cancer Patients

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00084123
First received: June 7, 2004
Last updated: July 9, 2009
Last verified: July 2009
History of Changes
  Purpose

The purpose of this study is to evaluate the effects of healing touch and relaxation therapy on cervical cancer patients undergoing chemotherapy and radiation treatment.


Condition Intervention Phase
Cervix Neoplasms
 Behavioral: Healing Touch Therapy
Behavioral: Relaxation Therapy
Behavioral: Standard Care
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Healing Touch in Advanced Cervical Cancer Patients: Immune Effects and Mechanisms

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • natural killer cell cytotoxicity [ Time Frame: Baseline to week 6 ] [ Designated as safety issue: No ]
  • T-cell counts [ Time Frame: Baseline to week 6 ] [ Designated as safety issue: No ]
  • side effects [ Time Frame: Baseline to week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • distress [ Time Frame: Baseline to week 6 ] [ Designated as safety issue: No ]
  • WBC and RBC [ Time Frame: Baseline to week 6 ] [ Designated as safety issue: No ]
  • days of treatment delay [ Time Frame: Baseline to week 6 ] [ Designated as safety issue: No ]
  • salivary cortisol [ Time Frame: Baseline to post-treatment ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: September 2002
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Healing Touch
Healing Touch Therapy
 Behavioral: Healing Touch Therapy
Active Comparator: Relaxation Therapy
Relaxation Therapy
 Behavioral: Relaxation Therapy
Placebo Comparator: Standard Care
Standard Care
 Behavioral: Standard Care
Standard Care

Detailed Description:

The side effects of chemotherapy and radiation treatment are often severe and can have devastating effects on the mental and physical well-being of cancer patients. This study will determine whether healing touch and relaxation therapy are effective in minimizing the side effects of chemotherapy and radiation treatment in cervical cancer patients.

Participants in this study will receive weekly chemotherapy and daily radiation treatments for 6 weeks. Participants will be randomly assigned to receive either standard care (SC), SC plus relaxation therapy, or SC plus healing touch therapy. The relaxation therapy consists of progressive muscle relaxation and guided imagery. The healing touch therapy involves an energy-based modality in which health care practitioners stimulate the energy fields surrounding the patient. A physician-completed assessment and measures of immune function will be used to assess the well-being and overall quality of life of participants.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stage Ib1-IVa cervical cancer
  • Treatment with concurrent chemotherapy and radiation at the University of Iowa Hospitals and Clinics

Exclusion Criteria:

  • Immunosuppressive disorders
  • Use of immunosuppressive medications
  • Transplant recipient
  • Metastatic or recurrent cervical cancer
  • History of any other type of cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00084123

Locations
United States, Iowa
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
National Center for Complementary and Alternative Medicine (NCCAM)
Investigators
Principal Investigator: Susan K Lutgendorf, MD University of Iowa
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00084123     History of Changes
Obsolete Identifiers: NCT00065091
Other Study ID Numbers: P20 AT000756-01
Study First Received: June 7, 2004
Last Updated: July 9, 2009
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Relaxation Techniques
Radiation
Drug Therapy
Healing Touch

Additional relevant MeSH terms:
Neoplasms
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
 Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 16, 2013